For bladder cancer, we seek to improve patient outcomes and reduce healthcare costs by delivering to the urological market an assay with enhanced ability to predict disease progression to an invasive or metastatic phenotype. Specifically, we will strive to validate and improve on an assay with potential to detect mutations in the p53 gene of bladder cancer cells that are exfoliated into the lumen of the bladder and collectable in either voided urines or bladder irrigations (washes). The assay to be examined is NIRCA(TM) (Non-Isotopic RNase Cleavage Assay) and was developed at Ambion, Inc. UroCor, Inc., this nation's largest provider of diagnostic services to the urology market, will determine the sensitivity and specificity of the NIRCA assay for p53 mutations in bladder cancer specimens. UroCor will also determine the frequency of heterozygosity of neutral alleles of the p53 gene in healthy individuals. In phase II, the expected clinical utility of p53 mutational analysis for predicting bladder cancer progression will be tested in the appropriate retrospective and prospective trials. This work will involve Ambion in a collaborative, consultative and contractual basis. Ambion will help train UroCor staff and assist in meeting Phase l goals. PROPOSED COMMERCIAL APPLICATIONS: The nationwide market for bladder cancer evaluations is about 750,000 tests per year. Analysis of p53 mutations would likely improve the prognostic value of these evaluations significantly. At about $100 per assay, this market has a potential value of $75MM. UroCor could expect to command a large portion of this market.